German Inspectors Fault Dr. Reddy’s Facility in India
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings.
At the company’s FTO 2 plant in Hyderabad, German inspectors found hundreds of out-of-specification results in product checks, attributed to “staff errors” without the required analysis of root causes, according to a report from EudraGMP.
The company’s monitoring systems are designed and executed in a way to systematically not document and report discrepancies, non-conformances, incidents or unusual events, the report said.
The FDA previously identified GMP problems at multiple Dr. Reddy’s sites, issuing a Form 483 report earlier this year and a warning letter in 2015.